Job Description
| 1. C&Q Strategy & Planning • Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. • Define system boundaries and identify direct/indirect impact systems. • Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope. • Develop C&Q plans, schedules, and resource forecasting. 2. Commissioning Activities • Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning. • Ensure systems are installed and operate per design specifications. • Coordinate with vendors and contractors during startup activities. • Review and approve commissioning documentation and test results. 3. Qualification Execution (IQ/OQ/PQ) • Author, review, and approve qualification protocols (IQ, OQ, PQ). • Ensure traceability from User Requirements Specifications (URS) through testing. • Execute or oversee protocol execution and ensure proper documentation of results. 4. Documentation & Compliance • Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards. • Maintain document lifecycle within electronic systems. • Support data integrity and ALCOA+ principles throughout qualification activities. • Prepare and support validation summary reports. 5. Risk Management & Change Control • Lead and document risk assessments related to system qualification. • Evaluate and manage change controls impacting validated systems. • Assess impact of deviations and implement corrective and preventive actions (CAPA). 6. Cross-functional Coordination • Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams. • Interface with system owners and technical authorities. • Provide technical guidance and mentorship to junior engineers and project team members. • Support project meetings, status reporting, and stakeholder communication. 7. Characterization Process • Develop the characterization protocols. • Execute the characterization activities. • Develop and review the characterization reports | |||
| 30 minutes | ||
|---|---|---|---|
| None |
Requirements
1. C&Q Strategy & Planning • Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. • Define system boundaries and identify direct/indirect impact systems. • Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope. • Develop C&Q plans, schedules, and resource forecasting. 2. Commissioning Activities • Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning. • Ensure systems are installed and operate per design specifications. • Coordinate with vendors and contractors during startup activities. • Review and approve commissioning documentation and test results. 3. Qualification Execution (IQ/OQ/PQ) • Author, review, and approve qualification protocols (IQ, OQ, PQ). • Ensure traceability from User Requirements Specifications (URS) through testing. • Execute or oversee protocol execution and ensure proper documentation of results. 4. Documentation & Compliance • Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards. • Maintain document lifecycle within electronic systems. • Support data integrity and ALCOA+ principles throughout qualification activities. • Prepare and support validation summary reports. 5. Risk Management & Change Control • Lead and document risk assessments related to system qualification. • Evaluate and manage change controls impacting validated systems. • Assess impact of deviations and implement corrective and preventive actions (CAPA). 6. Cross-functional Coordination • Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams. • Interface with system owners and technical authorities. • Provide technical guidance and mentorship to junior engineers and project team members. • Support project meetings, status reporting, and stakeholder communication. 7. Characterization Process • Develop the characterization protocols. • Execute the characterization activities. • Develop and review the characterization reports
Sr Engineer - Juncos, PR - 35630 • Juncos, PR, pr
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